BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4180332 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19879
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE PUMP REVEALED NO SIGNIFICANT ANOMALY. EOS HAD OCCURRED DUE TO TIME PROGRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNHAPPY WITH THE DOSES THAT TWO PHYSICIANS HAD INCREASED HER DOSE TO. THE PATIENT¿S PREVIOUS MANAGING HEALTHCARE PROVIDER (HCP) INCREASED THE MEDICATION DOSE TOO HIGH. IT WAS ALSO REPORTED THAT THE PUMP REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AT THE BEGINNING OF THE YEAR. ON THE DATE OF THIS REPORT, THE PUMP WAS EXPLANTED, AS THE PATIENT WANTED TO TRY TO LIVE WITHOUT IT. AT THE TIME OF THIS REPORT, THE PUMP WAS UNABLE TO BE READ, AS IT HAD REACH END OF SERVICE (EOS) AND WAS PROGRAMMED AND FILLED WITH SALINE. THE PUMP WAS PREVIOUSLY USED TO DELIVER CLONIDINE AND MORPHINE AT 7MG PER DAY. HOWEVER, THIS DOSE WAS NOT CLEAR OR CONFIRMED. SPECIFIC PATIENT SYMPTOMS, DETAILS REGARDING THE ERI AND EOS, TROUBLESHOOTING/DIAGNOSTICS, AND FINAL PATIENT OUTCOME WAS NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662539 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Other